Remote Versus In‐Person Follow‐up Programming After Subthalamic Deep Brain Stimulation for Parkinson's Disease: A Multicenter Randomized Noninferiority Trial

BACKGROUND: Remote programming of deep brain stimulation may improve access to specialized postoperative care for people with Parkinson's disease, but prospective randomized evidence remains limited. OBJECTIVE: We aimed to determine whether remote follow-up programming after standardized inpatient initiation is noninferior to conventional in-person follow-up programming for motor outcomes during the early postoperative period. METHODS: In this prospective, randomized, open-label, multicenter noninferiority trial, adults with idiopathic Parkinson's disease who recently underwent bilateral subthalamic nucleus deep brain stimulation implantation at six German centers were randomly assigned 1:1 to conventional in-person follow-up programming or remote follow-up programming through a secure telemedicine platform during the first 90 days after surgery. All participants underwent initial in-person postoperative programming before randomization. The primary outcome was the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III score at 90 days in the medication on and stimulation ON state. The prespecified noninferiority margin was 5 points. RESULTS: Fifty-two participants were randomly assigned. The per-protocol population included 26 participants in the conventional care group and 22 in the remote programming group. The between-group median difference of the primary endpoint was -2.5 points (95% confidence interval, -9.0 to 2.0), meeting the prespecified noninferiority criterion. Secondary clinical outcomes and patient-reported outcomes were broadly comparable between groups. Serious adverse events occurred at similar frequencies in both groups, and no deaths occurred. CONCLUSIONS: Remote follow-up programming after standardized inpatient initiation achieved motor outcomes noninferior to conventional in-person follow-up during the first 3 months, with no clear short-term safety signal.